Standardization activities in the field of thyroid function tests: A status report

Clinical Chemistry and Laboratory Medicine

Volumn 48, Issue 11, 2010, Pages 1577-1583

  Thienpont, Linda M ^a   Van Uytfanghe, Katleen ^a   Van Houcke, Sofie ^a  

^a GHENT UNIVERSITY   (Belgium)

Author keywords

Conventional reference measurement procedure; Measurand; Reference measurement procedure; Sample related effects; Traceability

Indexed keywords

LIOTHYRONINE; THYROID HORMONE; THYROTROPIN; THYROXINE;

ARTICLE; CALIBRATION; CLINICAL ASSESSMENT; HUMAN; INTERMETHOD COMPARISON; MATHEMATICAL PARAMETERS; PERFORMANCE; PRIORITY JOURNAL; STANDARDIZATION; THYROID FUNCTION TEST; THYROID HORMONE BLOOD LEVEL;

HUMANS; INTERNATIONAL AGENCIES; REFERENCE STANDARDS; RESEARCH REPORT; THYROID FUNCTION TESTS; THYROTROPIN; THYROXINE; TRIIODOTHYRONINE;

EID: 78751632503     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/CCLM.2010.321     Document Type: Article

References (33)

1. Vanderpump MP, Tunbridge WM, French JM, Appleton D, Bates D, Clark F, et al. The incidence of thyroid disorders in the community: a twenty-year follow-up of the Whickham Survey. Clin Endocrinol 1995;43:55-68.
2. Wang C, Crapo LM. The epidemiology of thyroid disease and implications for screening. Endocrinol Metab Clin North Am 1997;26:189-218. [Review].
3. Tunbridge WM, Vanderpump MP. Population screening for autoimmune thyroid disease. Endocrinol Metab Clin North Am 2000;29:239-53. [Review].
4. Bjoro T, Holmen J, Krüger O, Midthjell K, Hunstad K, Schreiner T, et al. Prevalence of thyroid disease, thyroid dysfunction and thyroid peroxidase antibodies in a large, unselected population. The Health Study of Nord-Trondelag (HUNT). Eur J Endocrinol 2000;143:639-47.
5. Leese GP, Flynn RV, Jung RT, Macdonald TM, Murphy MJ, Morris AD. Increasing prevalence and incidence of thyroid disease in Tayside, Scotland: the Thyroid Epidemiology Audit and Research Study (TEARS). Clin Endocrinol 2008;68:311-6.
6. Samuels MH. Subclinical thyroid disease in the elderly. Thyroid 1998;8:803-13. [Review].
7. Stuckey BG, Kent GN, Allen JR. The biochemical and clinical course of postpartum thyroid dysfunction: the treatment decision. Clin Endocrinol 2001;54:377-83.
8. Stockigt J. Assessment of thyroid function: towards an integrated laboratory-clinical approach. Clin Biochem Rev 2003;24:109-22.
9. National Academy of Clinical Biochemistry (NACB). Laboratory medicine practice guidelines: laboratory support for the diagnosis and monitoring of thyroid disease. NACB, Demers LM, Spencer CA, 2002.
10. Ekins R. The science of free hormone measurement. Proc UK NEQAS Meeting 1998;3:35-59.
11. Christofides ND, Wilkinson E, Stoddart M, Ray DC, Beckett GJ. Assessment of serum thyroxine binding capacity-dependent biases in free thyroxine assays. Clin Chem 1999;45:520-5.
12. Sapin R. Serum thyroxine binding capacity-dependent bias in five free thyroxine immunoassays: assessment with serum dilution experiments and impact on diagnostic performance. Clin Biochem 2001;34:367-71.
13. Midgley JE. Direct and indirect free thyroxine assay methods: theory and practice. Clin Chem 2001;47:1353-63. [Review].
14. Lee RH, Spencer CA, Mestman JH, Miller EA, Petrovic I, Braverman LE, et al. Free T4 immunoassays are flawed during pregnancy. Am J Obstet Gynecol 2009;200:260.e1-6.
15. International Federation of Clinical Chemistry and Laboratory Medicine. Available at: http://www.ifcc.org. Accessed: 15 March 2010.
16. International Organization for Standardization. In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin - metrological traceability of values assigned to calibrators and control materials. EN/ISO 17511. Geneva: ISO, 2003.
17. Thienpont LM, Van Uytfanghe K, Marriott J, Stokes P, Siekmann L, Kessler A, et al. Metrological traceability of total thyroxine measurements in human serum. Efforts to establish a network of reference measurement laboratories. Clin Chem 2005;51:161-8.
18. Joint Commission for Traceability in Laboratory Medicine (JCTLM) Database of higher order reference materials, measurement methods/procedures and services. Available at: http://www.bipm.org/jctlm/. Accessed: 15 March 2010.
19. Thienpont LM, Van Uytfanghe K, Marriott J, Stokes P, Siekmann L, Kessler A, et al. Feasibility study of the use of frozen human sera in split-sample comparison of immunoassays with candidate reference measurement procedures for total thyroxine and total triiodothyronine measurement. Clin Chem 2005;51:2303-11.
20. Thienpont LM, Beastall G, Christofides ND, Faix JD, Ieiri T, Miller WG, et al. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), Scientific Division Working Group for Standardization of Thyroid Function Tests (WG-STFT). Measurement of free thyroxine in laboratory medicine - proposal of measurand definition. Clin Chem Lab Med 2007;45:563-4.
21. Holm SS, Hansen SH, Faber J, Staun-Olsen P. Reference methods for the measurement of free thyroid hormones in blood: evaluation of potential reference methods for free thyroxine. Clin Biochem 2004;37:85-93. [Review].
22. Thienpont LM, Beastall G, Christofides ND, Faix JD, Ieiri T, Jarrige V, et al. IFCC Scientific Division Working Group for Standardization of Thyroid Function Tests (WG-STFT). Proposal of a candidate international conventional reference measurement procedure for free thyroxine in serum. Clin Chem Lab Med 2007;45:934-6.
23. World Health Organization. International reference materials. Available at: http://www.who.int/bloodproducts/ref-materials/en/. Accessed: 15 March 2010.
24. CLSI. Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; Approved Guideline. CLSI document C37-A (ISBN 1-56238-392-2). CLSI, Wayne, PA, 1999.
25. Van Uytfanghe K, Stöckl D, Ross HA, Thienpont LM. Use of frozen sera for FT4 standardization: investigation by equilibrium dialysis combined with isotope dilution-mass spectrometry and immunoassay. Clin Chem 2006;52:1817-21.
26. Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, et al. Report of the IFCC Working Group for Standardization of Thyroid Function Tests (WG-STFT) - Part 1: Thyroid stimulating hormone. Clin Chem 2010;56:902-11.
27. Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, et al. Report of the IFCC Working Group for Standardization of Thyroid Function Tests (WG-STFT) - Part 2: Free thyroxine and total triiodothyronine. Clin Chem 2010;56:912-20.
28. Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, et al. Report of the IFCC Working Group for Standardization of Thyroid Function Tests (WG-STFT) - Part 3: Total thyroxine and total triiodothyronine. Clin Chem 2010;56:921-9.
29. Yue B, Rockwood AL, Sandrock T, La'ulu SL, Kushnir MM, Meikle AW. Free thyroid hormones in serum by direct equilibrium dialysis and online solid-phase extraction - liquid chromatography/tandem mass spectrometry. Clin Chem 2008;54:642-51.
30. Twentyman J, Cradic K, Ryan B, Grebe S, Singh SR. Accurate free thyroxine (FT4) quantitation in human serum by combined equilibrium dialysis and direct mass spectrometry measurement [abstract]. Clin Chem 2007;53: D113.
31. Westgard QC. Desirable specifications for total error, imprecision, and bias, derived from intra-and inter-individual biologic variation. Available at: http://www.westgard.com/biodatabase1.htm. Accessed 15 March 2010.
32. Donadio S, Pascual A, Thijssen JH, Ronin C. Feasibility study of new calibrators for thyroid-stimulating hormone (TSH) immunoprocedures based on remodeling of recombinant TSH to mimic glycoforms circulating in patients with thyroid disorders. Clin Chem 2006;52:286-97.
33. Donadio S, Morelle W, Pascual A, Romi-Lebrun R, Michalski JC, Ronin C. Both core and terminal glycosylation alter epitope expression in thyrotropin and introduce discordances in hormone measurements. Clin Chem Lab Med 2005;43:519-30.